CAPA SOFTWARE

Optimise your digital CAPA management

Ma­xi­mi­se the ef­fi­ci­en­cy of your cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA) th­rough au­to­ma­ted, di­gi­tal work­flows. Gua­ran­tee the qua­li­ty of your pro­ducts and ser­vices while at the same time com­ply­ing with in­ter­nal and le­gal requirements. 

Con­side­ra­ti­on of in­ter­nal and le­gal requirements 

Au­to­ma­ted for­war­ding and es­cala­ti­on management 

Real-time over­view of all de­via­ti­on processes 

Arrow with the word "Watch video" pointing downwards.

You are curr­ent­ly vie­w­ing a pla­ce­hol­der con­tent from You­tube. To ac­cess the ac­tu­al con­tent, click the but­ton be­low. Plea­se note that do­ing so will share data with third-par­ty providers.

More In­for­ma­ti­on

» dls | capa «

Software for your CAPA processes

Con­trol your pro­duc­tion-re­la­ted qua­li­ty ma­nage­ment pro­ces­ses, in­clu­ding cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA), with our ad­van­ced di­gi­tal work­flows. Our in­te­gra­ted so­lu­ti­ons com­ple­te­ly trans­form your exis­ting pa­per-ba­sed pro­cess into a di­gi­tal work­flow — from re­cor­ding to completion.

Thanks to our ef­fi­ci­ent work­flow sys­tem, the di­gi­tal CAPA form is au­to­ma­ti­cal­ly for­ward­ed to the next in­s­tance. If time is ex­cee­ded, the re­min­der and es­cala­ti­on ma­nage­ment sys­tem proac­tively in­ter­ven­es to avo­id de­lays. In ad­di­ti­on, an in­te­gra­ted re­gu­la­ti­on for task rou­ting gua­ran­tees the aut­ho­ri­sa­ti­on of sub­sti­tu­tes so that the con­ti­nui­ty of pro­ces­ses is en­su­red even in the event of absences.

How can you benefit from the CAPA software?

Process safety 

Af­ter each step, the work­flow sys­tem en­su­res that the CAPA is for­ward­ed to the per­son in char­ge. The es­cala­ti­on sys­tem ta­kes ef­fect in case of missed deadlines. 

Data integrity 

All cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CA­PAs) are re­cor­ded di­gi­tal­ly, which pre­vents the loss of re­le­vant in­for­ma­ti­on. Your data is also pro­tec­ted against un­aut­ho­ri­sed ac­cess and pos­si­ble damage. 

Constant availability 

Ac­cess your data at any time and from any­whe­re — re­gard­less of your location. 

Central information platform 

Use d.velop do­cu­ments (form­er­ly d.3ecm) as a cen­tral source of in­for­ma­ti­on to re­trie­ve your data efficiently. 

Traceability 

Link CA­PAs with mo­du­les such as ch­an­ge ma­nage­ment (ch­an­ge con­trol) for seam­less do­cu­men­ta­ti­on of all in­di­vi­du­al pro­ces­ses. CA­PAs can be in­itia­ted, for ex­am­p­le, from de­via­ti­on re­ports or can in­itia­te a ch­an­ge process. 

Transparency 

Every aut­ho­ri­sed em­ployee has ac­cess to the cur­rent sta­tus of all CAPA pro­ces­ses, re­gard­less of their role in the process. 

Individual configuration 

Cus­to­mi­se the mo­du­les to your spe­ci­fic re­qui­re­ments to fa­ci­li­ta­te the on­boar­ding pro­cess for your colleagues. 

Reports 

Crea­te com­pre­hen­si­ve re­ports and sta­tis­tics on your CA­PAs for well-foun­ded decisions. 

Digitise your CAPA processes now 

Get a first overview. 

Mapping of a notebook on which the QM workflows of Digital Life Sciences are mapped, Complaint, Deviation Control, CAPA, Change Control
PDF Do­cu­ment

The di­gi­tal forms are also con­ver­ted to a PDF/A in par­al­lel. This way, em­ployees who are not in­vol­ved in the pro­cess can also gain in­sight into the work­flow and the do­cu­ment can be shared with ex­ter­nal par­ties if required.

dls | capa

What is a CAPA process?

The CAPA pro­cess (Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion) al­lows drug safe­ty errors/deviations to be sys­te­ma­ti­cal­ly re­cor­ded and pro­ces­sed in con­for­mi­ty with re­gu­la­to­ry and in­ter­nal spe­ci­fi­ca­ti­ons. In the pro­cess, CAPA ma­nage­ment fo­cu­ses on the eli­mi­na­ti­on of non­con­for­mi­ties (cor­rec­ti­ve ac­tion) and the avo­id­ance of po­ten­ti­al non­con­for­mi­ties (pre­ven­ti­ve action).

Non­con­for­mi­ties fol­low, for ex­am­p­le, from a pro­cess de­via­ti­on that re­sults in cer­tain cor­rec­ti­ve ac­tions that can eli­mi­na­te the exis­ting problem.

For ex­am­p­le, a pre­ven­ti­ve me­a­su­re could re­sult from an OOT ana­ly­sis. No ac­tu­al non­con­for­mi­ty has oc­cur­red here yet, but a de­gra­da­ti­on of the va­li­da­ted pro­cess has been noted.

The CAPA pro­cess can thus en­su­re con­ti­nuous pro­duct quality.

Au­dit Trail

Every ac­tion in the pro­cess is au­to­ma­ti­cal­ly do­cu­men­ted by the sys­tem ac­cor­din­gly. In­te­gra­ted au­dit trail func­tions en­su­re high traceability.

Form

The di­gi­tal form is fil­led out step by step and pro­vi­ded with the re­le­vant ent­ries and data. Fields with a blue back­ground are man­da­to­ry. Pre­de­fi­ned va­lue sets and drop-down func­tions make it easy for users to fill out the form.

Pro­cess Steps

Af­ter pro­ces­sing the in­di­vi­du­al steps (1. In­itia­ti­on, 2. Re­cor­ding of me­a­su­res and risks, 3. Ex­pert com­mit­tee, etc.), the work­flow sys­tem au­to­ma­ti­cal­ly sends tasks and mes­sa­ges to the re­spon­si­ble agents or work­flow par­ti­ci­pan­ts. Once all steps have been pro­ces­sed, the work­flow is con­side­red complete.

1. Step: Initiation
The CAPA pro­cess is in­itia­ted by the per­son re­spon­si­ble for the pro­cess of the af­fec­ted de­part­ment. He or she re­cords the re­le­vant data for CAPA. The pro­cess is then for­ward­ed to the ap­poin­ted CAPA responsible.

Would you like a live insight into the CAPA software?

Get a com­pre­hen­si­ve live in­sight into the pos­si­bi­li­ties of pro­duc­tion-re­la­ted qua­li­ty ma­nage­ment pro­ces­ses wi­thin just 45 mi­nu­tes using a spe­ci­fic use case. Learn how you can ef­fi­ci­ent­ly use Di­gi­tal Life Sci­en­ces so­lu­ti­ons to op­ti­mi­ze your pro­duc­tion-re­la­ted QM pro­ces­ses, such as com­plaints (Com­plaint Ma­nage­ment), de­via­ti­on re­ports (de­via­ti­on con­trol), cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA) and ch­an­ge ma­nage­ment (ch­an­ge con­trol) th­rough our di­gi­tal workflows.

Features of the Corrective And Preventive Actions software

Regulatory requirements in the CAPA process

ISO 9001:2015, Chap­ter 8 

ISO 13485:2016, Chap­ter 8 

EU GMP Gui­de Part 1, Chap­ter 8 

33 Good reasons for a cooperation with Digital LS

You’re not con­vin­ced yet? You’re not con­vin­ced yet? Find out about 33 good re­asons spea­king for a co­ope­ra­ti­on with Di­gi­tal Life Sci­en­ces GmbH. We will show you re­asons from the provider’s point of view, from the soft­ware point of view and other ge­ne­ral re­asons that di­stin­gu­ish us.

Customer review on the CAPA Management

You might also like…

CAPA Ma­nage­ment is a com­po­nent of the Di­gi­tal Life Sci­en­ces so­lu­ti­on suite. Each pro­duct is powerful on its own, but when used tog­e­ther they are even better.

Emblem for the software solution Document Control

Document Control software

Whe­ther work / pro­cess in­s­truc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons or other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them all di­gi­tal­ly with the do­cu­ment con­trol software.

Emblem for the software solution training management

Training Management software

Ex­tend the “Do­cu­ment Con­trol” mo­du­le to ac­tively plan and re­cord the qua­li­fi­ca­ti­ons of your em­ployees with our trai­ning ma­nage­ment software.

Emblem for the e-learning software solution

E‑learning software

Use the new soft­ware “E‑Learning” to train your em­ployees di­gi­tal­ly. Crea­te an e‑learning cour­se ac­cor­ding to your wis­hes using Mi­cro­soft Power­Point or in­te­gra­te exis­ting presentations.

Frequently asked questions (FAQs) about CAPA

In the ad­mi­nis­tra­ti­on, time spe­ci­fi­ca­ti­ons can be en­te­red for each pro­cess step. Re­min­der mes­sa­ges are sent be­fo­re the pro­cess steps are due. The re­min­der mes­sa­ge is sent to the pro­ces­sor of the task, the coor­di­na­tor and the con­fi­gu­red group that is to be in­for­med about the re­min­der (for ex­am­p­le, QA). A re­min­der is sent with the con­fi­gu­red subject.

If ad­di­tio­nal files are re­qui­red for a pro­cess, at­tach­ments can be uploa­ded in all pro­cess steps and lin­ked to the cur­rent pro­cess. The at­tach­ments are stored un­der a cor­re­spon­ding do­cu­ment type in the DMS and can be view­ed in CAPA un­der ‘At­tach­ments’ by all pro­cess par­ti­ci­pan­ts. You can con­fi­gu­re which file ty­pes can be sa­ved as at­tach­ments and how lar­ge the files can be.

It can be con­fi­gu­red so that the pro­cess can be can­cel­led at any pro­cess step. For the can­cel­la­ti­on, it is re­qui­red to in­di­ca­te a re­ason in a man­da­to­ry field. Only the coor­di­na­tor of the pro­cess is al­lo­wed to cancel.

Ha­ving en­te­red a me­a­su­re, you can save it as a tem­p­la­te in the me­a­su­re ta­ble. The tem­pla­tes are available for in­ser­ti­on in a CAPA. The due date for the me­a­su­re is cal­cu­la­ted ba­sed on the du­ra­ti­on en­te­red in the template.

In prin­ci­ple, a pro­cess step is com­ple­ted with an elec­tro­nic si­gna­tu­re and can no lon­ger be cor­rec­ted. With the func­tion ‘Step back’ the pro­cess can be re­tur­ned to a pre­vious pro­cess step. The user who has com­ple­ted this step re­cei­ves it again for editing and the pro­cess con­ti­nues from this step. Any re­turn to a pre­vious step is re­cor­ded in the au­dit trail.

CAPA stands for Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tions. This pro­cess is a cen­tral com­po­nent of the qua­li­ty ma­nage­ment sys­tem (QMS) and ser­ves to iden­ti­fy and rec­ti­fy pro­blems and pre­vent fu­ture incidents.

Cor­rec­ti­ve ac­tions are ai­med at ana­ly­sing exis­ting pro­blems or de­via­ti­ons and im­ple­men­ting per­ma­nent so­lu­ti­ons to pre­vent their re­cur­rence. Pre­ven­ti­ve ac­tions, on the other hand, deal with the iden­ti­fi­ca­ti­on of po­ten­ti­al pro­blems and the in­tro­duc­tion of me­a­su­res to pre­vent them from oc­cur­ring in the first place.

The im­portance of CAPA lies in its abili­ty to pro­mo­te the con­ti­nuous im­pro­ve­ment of a company’s pro­ces­ses and pro­ducts. By sys­te­ma­ti­cal­ly re­cor­ding, ana­ly­sing and eli­mi­na­ting er­rors and ta­king pre­cau­ti­ons against po­ten­ti­al risks, CAPA makes a si­gni­fi­cant con­tri­bu­ti­on to im­pro­ving pro­duct qua­li­ty, com­ply­ing with re­gu­la­to­ry re­qui­re­ments and in­cre­asing cus­to­mer satisfaction.

In all pro­cess steps that fol­low the in­itia­ti­on, you can for­ward the pro­cess step to an­o­ther per­son. The recipient’s aut­ho­riza­ti­on is che­cked du­ring the selection.

The es­sen­ti­al data of a CAPA is trans­fer­red to the at­tri­bu­tes of the data re­cord. This al­lows you to search and ana­ly­ze the CA­PAs you have crea­ted. The ana­ly­ses can be ex­por­ted as PDF, EXCEL or WORD documents.

The CAPA pro­cess flow has been de­si­gned in ac­cordance with the GxP re­gu­la­ti­ons and crea­ted in con­sul­ta­ti­on with QM ex­perts. Against the back­ground of the va­li­da­ti­on do­cu­men­ta­ti­on, the pro­cess steps are the­r­e­fo­re man­da­to­ry. Ho­we­ver, each pro­cess step con­ta­ins a ‘Cus­tom Pa­nel’, which can be used to dis­play fur­ther in­for­ma­ti­on or in­itia­te actions.

In the work­flow ad­mi­nis­tra­ti­on, you can con­fi­gu­re the names of the pro­cess steps, field names and datasets.

When working on a pro­cess step, only this step can be pro­ces­sed, but the other pro­cess steps are still visible.

The im­ple­men­ta­ti­on of the CAPA pro­cess usual­ly fol­lows se­ve­ral stan­dar­di­sed steps that en­su­re the sys­te­ma­tic and ef­fec­ti­ve pro­ces­sing of cor­rec­ti­ve and pre­ven­ti­ve measures:

1. Pro­blem identification

  • De­via­ti­ons: Iden­ti­fi­ca­ti­on of pro­blems such as pro­duc­tion er­rors, com­plaints or in­ter­nal au­dit re­sults that in­di­ca­te a de­via­ti­on from the de­fi­ned processes.
  • Non-con­for­mi­ties: Iden­ti­fi­ca­ti­on of dis­crepan­ci­es with re­gard to re­gu­la­to­ry re­qui­re­ments, such as the EU GMP gui­de­lines, as well as in­ter­nal qua­li­ty standards.

2. Root cau­se analysis

  • In­ves­ti­ga­ti­on: Sys­te­ma­tic ana­ly­sis to de­ter­mi­ne the root cau­se of the problem.
  • Data ana­ly­sis: Ana­ly­sis of pro­cess and pro­duc­tion data to de­tect pat­terns that help iden­ti­fy root causes.

3. Cor­rec­ti­ve actions

  • De­ve­lo­p­ment of me­a­su­res: Ba­sed on the root cau­se ana­ly­sis, con­cre­te steps are de­ve­lo­ped to rec­ti­fy the pro­blems. This can in­clude ad­jus­t­ments to work in­s­truc­tions, tech­ni­cal spe­ci­fi­ca­ti­ons or pro­duc­tion processes.
  • Im­ple­men­ta­ti­on: The me­a­su­res de­ve­lo­ped are in­te­gra­ted into the re­le­vant pro­ces­ses. Ad­jus­t­ments to the soft­ware or pro­duc­tion lay­out may be necessary.

4. Pre­ven­ti­ve actions

  • Risk eva­lua­ti­on: Once the pro­blem has been re­sol­ved, a tho­rough eva­lua­ti­on is car­ri­ed out to de­ter­mi­ne whe­ther si­mi­lar pro­blems could oc­cur in other sec­tions or processes.
  • Pre­ven­ti­ve me­a­su­res: Pre­ven­ti­ve ac­tions are im­ple­men­ted to pre­vent re­cur­ren­ces of the pro­blem. This in­cludes trai­ning for staff, im­pro­ve­ments in pro­cess mo­ni­to­ring and ad­jus­t­ments in the area of qua­li­ty control.

5. Ef­fec­ti­ve­ness check

  • Ve­ri­fi­ca­ti­on: Once the cor­rec­ti­ve and pre­ven­ti­ve me­a­su­res have been im­ple­men­ted, a re­view is car­ri­ed out to en­su­re that the me­a­su­res are ef­fec­ti­ve and that the pro­blem has been sol­ved sustainably.
  • Long-term mo­ni­to­ring: Con­ti­nuous mo­ni­to­ring of the pro­ces­ses and re­sults en­su­res that the pre­ven­ti­ve ac­tions are suc­cessful and that no new de­via­ti­ons occur.

6. Do­cu­men­ta­ti­on and reporting

  • Log­ging: All steps of the CAPA pro­cess — from pro­blem iden­ti­fi­ca­ti­on to ef­fec­ti­ve­ness check — are com­pre­hen­si­ve­ly do­cu­men­ted. This is es­sen­ti­al for pro­ving com­pli­ance with re­gu­la­to­ry requirements.
  • Au­dit Trail: A com­ple­te au­dit trail is pro­vi­ded in a di­gi­tal CAPA sys­tem, which pro­ves that every me­a­su­re was car­ri­ed out and do­cu­men­ted properly.

7. Con­ti­nuous improvement

  • The CAPA pro­cess is cy­cli­cal and pro­mo­tes the con­ti­nuous im­pro­ve­ment of the qua­li­ty ma­nage­ment sys­tem (QMS). The in­sights gai­ned are in­cor­po­ra­ted into stra­te­gic plan­ning and pro­cess optimisation.

Th­rough this sys­te­ma­tic ap­proach, the CAPA pro­cess en­su­res that pro­blems are not only re­sol­ved in the short term, but that fu­ture risks are also mi­ni­mi­sed, which ul­ti­m­ate­ly leads to a sus­tainable im­pro­ve­ment in quality.

Quick contact

Do you have a ques­ti­on about the CAPA module?
Our sa­les team will help you prompt­ly and gladly.